Prepare regulatory documents, including new drug applications (NDAs), biologics license applications (BLAs), and amendments.
Monitor and interpret regulatory guidelines and updates, ensuring compliance with evolving regulations.
Collaborate with cross-functional teams, including clinical, quality, and manufacturing, to support regulatory submissions and compliance.
Support in develop and implementation of regulatory strategies to support product lifecycle management, including labeling and advertising, etc.
Maintain accurate and up-to-date records of regulatory submissions and communications.
Candidate must be Pharm-D.
Job Type: Full-time
Education:

• Bachelor's (Preferred)

Experience:

• Regulatory Affairs in Pharmaceutical Company: 2 years (Preferred)